This guidance provides recommendations to sponsors, Contract Research Organizations (CROs), clinical investigators, and others involved in the capture, review, and retention of electronic source data in FDA-regulated clinical investigations. In an effort to streamline and modernize clinical investigations this guidance promotes capturing source data in electronic form, and it isintended to assist in ensuring the reliability, quality, integrity, and traceability of data from electronic source to electronic regulatory submission.
This guidance addresses source data in clinical investigations used to fill the predefined fields in an electronic case report form (eCRF), according to the protocol. The guidance discusses the following topics related to electronic source data:
- Identification and specification of authorized source data originators
- Creation of data element identifiers to facilitate examination of the audit trail by sponsors, FDA, and other authorized parties
- Ways to capture source data into the eCRF using either manual or electronic methods
- Clinical investigator(s) responsibilities with respect to reviewing and retaining electronic data
- Use and description of computerized systems in clinical investigations
This guidance is intended to be used together with the FDA guidance for industry on Computerized Systems Used in Clinical Investigations (the computerized systems guidance) and FDA regulation on Electronic Records and Electronic Signatures. Electronic structures and standards related to electronic submissions are out of scope for this guidance.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.